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German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET) (DDIET)

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

diet intervention

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring insulin sensitivity, type 2 diabetes, diet intervention

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 2 diabetic patients
disease duration for five years or less,
age of 69 years or less,
body mass index of 30 kg/m2 or more,
hemoglobin A1c of 5,5 % to 9%
patient should be on standard diet or metformin +/- acarbose monotherapy
patient should be without exclusion criteria for coffee consumption

Exclusion Criteria:

disease duration more than five years,
age of > 69 years,
body mass index of < 30 kg/m2,
hemoglobin A1c < 5,5 % or > 9%
if patient becomes insulin therapy
if patient has exclusion criteria for coffee consumption
if patient is non-compliant with study protocol
if patient is pregnant
if patient has acute infection
if patient has anaemia
if patient has malignancies
if patient has autoimmune or immune compromising diseases including HIV/AIDS
if patient has psychiatric diseases or addiction

Sites / Locations

German Diabetes Center
Charite, Department of Internal Medicine
University Hospital, Department of Internal Medicine III
University Hospital, Department of Internal Medicine I
Klinikum der Universität München (KUM)
University Hospital, Department of Internal Medicine IV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hypocaloric diet containing increased fibers and coffee

hypocaloric diet containing red meat

Arm Description

In the intervention group the patients are allowed to eat only white meat and fish. They also need to increase their daily fiber intake to 50grams and drink 5 cups of coffee a day.

control group (n=20): diet according to the ADA/EASD guidelines (50% carbohydrates, 20% proteins, 30% fat). In the control group the patients should eat 150 grams of red meat a day and are not allowed to consume alcohol, coffee and whole grains.

Outcomes

Primary Outcome Measures

whole body insulin sensitivity

measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Secondary Outcome Measures

total body fat

MRI measurement of the effects of 8-week diet intervention on total body fat

intramyocellular lipids

MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle

skeletal muscle mitochondrial function - insulin signaling

muscle biopsy for assessment of insulin signaling

hepatocellular lipids

MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL)

skeletal muscle mitochondrial function - phosphate-recovery time

skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS

insulin secretion

measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test

pancreatic fat

MRI measurement of the effects of 8-week diet intervention on pancreatic fat

Full Information

NCT ID

NCT01409330

First Posted

June 8, 2011

Last Updated

June 2, 2023

Sponsor

German Diabetes Center

1. Study Identification

Unique Protocol Identification Number

NCT01409330

Brief Title

German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)

Acronym

DDIET

Official Title

Short Term Diet Intervention in Newly Diagnosed Type 2 Diabetes. a Randomised, Multicentric, Controlled, Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

February 2011 (Actual)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

German Diabetes Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Diet intervention according to the German Diabetes Risk Score in newly diagnosed type 2 diabetes. This study aims to explore the effect of diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) in a multicenter setting.

Detailed Description

This study is a randomised, multicenter controlled trial Our Aim is to test the effects of an 8-week diet lacking red meat, containing increased fibers and coffee (verum) versus standard recommendation (control)in a multicenter setting. We are expecting that the verum diet will improve insulin sensitivity and insulin secretion due to reductions in visceral and hepatic fat along with improved adipocyte cytokine secretion profiles

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

insulin sensitivity, type 2 diabetes, diet intervention

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

hypocaloric diet containing increased fibers and coffee

Arm Type

Experimental

Arm Description

In the intervention group the patients are allowed to eat only white meat and fish. They also need to increase their daily fiber intake to 50grams and drink 5 cups of coffee a day.

Arm Title

hypocaloric diet containing red meat

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

diet intervention

Intervention Description

8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.

Primary Outcome Measure Information:

Title

whole body insulin sensitivity

Description

measurement of whole body insulin sensitivity with hyperinsulinamic euglicamic clamp

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

total body fat

Description

MRI measurement of the effects of 8-week diet intervention on total body fat

Time Frame

8 weeks

Title

intramyocellular lipids

Description

MRS measurement to investigate the effects of diet intervention on ectopic lipid content in skeletal muscle

Time Frame

8 weeks

Title

skeletal muscle mitochondrial function - insulin signaling

Description

muscle biopsy for assessment of insulin signaling

Time Frame

8 weeks

Title

hepatocellular lipids

Description

MRS measurement to investigate the effects of diet intervention on ectopic lipid content in liver(HCL)

Time Frame

8 weeks

Title

skeletal muscle mitochondrial function - phosphate-recovery time

Description

skeletal muscle mitochondrial function in vivo assessed as phosphate-recovery time with MRS

Time Frame

8 weeks

Title

insulin secretion

Description

measurement of insulin secretion with glucagon test, mixed-meal test and intravenous glucose tolerance test

Time Frame

8 weeks

Title

pancreatic fat

Description

MRI measurement of the effects of 8-week diet intervention on pancreatic fat

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 diabetic patients disease duration for five years or less, age of 69 years or less, body mass index of 30 kg/m2 or more, hemoglobin A1c of 5,5 % to 9% patient should be on standard diet or metformin +/- acarbose monotherapy patient should be without exclusion criteria for coffee consumption Exclusion Criteria: disease duration more than five years, age of > 69 years, body mass index of < 30 kg/m2, hemoglobin A1c < 5,5 % or > 9% if patient becomes insulin therapy if patient has exclusion criteria for coffee consumption if patient is non-compliant with study protocol if patient is pregnant if patient has acute infection if patient has anaemia if patient has malignancies if patient has autoimmune or immune compromising diseases including HIV/AIDS if patient has psychiatric diseases or addiction

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Roden, MD

Organizational Affiliation

German Diabetes Center

Official's Role

Study Director

Facility Information:

Facility Name

German Diabetes Center

City

Duesseldorf

State/Province

NRW

ZIP/Postal Code

40225

Country

Germany

Facility Name

Charite, Department of Internal Medicine

City

Berlin

Country

Germany

Facility Name

University Hospital, Department of Internal Medicine III

City

Dresden

Country

Germany

Facility Name

University Hospital, Department of Internal Medicine I

City

Heidelberg

Country

Germany

Facility Name

Klinikum der Universität München (KUM)

City

Munich

Country

Germany

Facility Name

University Hospital, Department of Internal Medicine IV

City

Tübingen

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

30619502

Citation

Karusheva Y, Kunstein L, Bierwagen A, Nowotny B, Kabisch S, Groener JB, Fleitmann AK, Herder C, Pacini G, Strassburger K, Haring HU, Nawroth PP, Pfeiffer AFH, Burkart V, Mussig K, Roden M, Szendroedi J. An 8-week diet high in cereal fiber and coffee but free of red meat does not improve beta-cell function in patients with type 2 diabetes mellitus: a randomized controlled trial. Nutr Metab (Lond). 2018 Dec 29;15:90. doi: 10.1186/s12986-018-0324-5. eCollection 2018.

Results Reference

derived

PubMed Identifier

26070589

Citation

Ziegler D, Strom A, Nowotny B, Zahiragic L, Nowotny PJ, Carstensen-Kirberg M, Herder C, Roden M. Effect of Low-Energy Diets Differing in Fiber, Red Meat, and Coffee Intake on Cardiac Autonomic Function in Obese Individuals With Type 2 Diabetes. Diabetes Care. 2015 Sep;38(9):1750-7. doi: 10.2337/dc15-0466. Epub 2015 Jun 12.

Results Reference

derived

PubMed Identifier

25425219

Citation

Nowotny B, Zahiragic L, Bierwagen A, Kabisch S, Groener JB, Nowotny PJ, Fleitmann AK, Herder C, Pacini G, Erlund I, Landberg R, Haering HU, Pfeiffer AF, Nawroth PP, Roden M. Low-energy diets differing in fibre, red meat and coffee intake equally improve insulin sensitivity in type 2 diabetes: a randomised feasibility trial. Diabetologia. 2015 Feb;58(2):255-64. doi: 10.1007/s00125-014-3457-8. Epub 2014 Nov 26. Erratum In: Diabetologia. 2016 Jun;59(6):1329.

Results Reference

derived

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German Diabetes-Diet-Intervention and Energy Restriction-Trial (DDIET)

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